Edible compositions for preventing hair loss

ABSTRACT

The present invention provides compositions comprising hydrolyzed gelatin or a mixture of hydrolyzed gelatin and gelatin, and the same compositions for use in methods comprising administering a low dose of the compositions useful in prophylaxis and treatment of hair loss in humans and shedding in animals. The compositions provide a palatable, malleable and well-tolerated product.

FIELD OF THE INVENTION

The present invention provides compositions and methods useful asprophylaxis and treatment of hair loss in humans and shedding inanimals. The compositions comprise certain concentrations of gelatin andprovide a palatable, malleable and well-tolerated edible product.

BACKGROUND OF THE INVENTION Hair Loss

Hair loss in men and women has many genetic and physiological andfactors. The most common form of balding is Androgenetic Alopecia, oralso known as male pattern baldness, which affects over 50% of Caucasianmen. Non-genetic events which can trigger hair loss include pregnancyand childbirth; menopause; severe emotional stress; rapid or profoundweight loss; malnutrition; medical intervention including surgery and/orradiation; illness; chemotherapy; and hair abuse. Several dietarysupplements and topical formulations are commercially available fortreatment of hair loss and the promotion of hair growth. None of theso-called “hair growth stimulants” have proven to be very efficacious.

Gelatin

Gelatin is extracted from by-products of the meat industry including theskin, connective tissue and bones of animals, and comprises primarilyproteins. Gelatin is a transparent, essentially odorless and tastelesspowder that became a popular consumable in the 1890s when it was firstdeveloped and promoted as a commercial product by Charles Knox, founderof the Knox Gelatin Corporation.

Gelatin has long been a key ingredient for “jelled” desserts, frozendrinks, and soft, chewy candies. Gelatin may be prepared from kosheranimals, or from fish, to comply with particular dietary laws.Vegetarians may substitute similar jellying agents such as agar, whichchemically is not gelatin.

In addition to its use in foodstuff, gelatin, with its dissolvablestructure, is also used to manufacture capsules (both hard and“soft-gel”) in the pharmaceutical and neutraceutical industries. It alsohas industrial and biomedical applications including as an ingredient infilm coatings and medical devices such as artificial heart valves,matrices and implants.

Health Benefits of Gelatin

Although gelatin has been publicized for decades as a good source ofprotein, there is little hard scientific evidence to support thestatements made for gelatin products. For example, gelatin containsprotein, but in an incomplete form for mammalian nutrition.

Gelatin has been promoted as a food supplement to improve hair and nailappearance and growth. In fact, the body already manufactures abundantamounts of the amino acids that gelatin provides, and no solidexperimental evidence has proven whether extra supplies of thesenutrients will help build or maintain healthy hair and nails.

U.S. Pat. No. 4,749,684 teaches a method of promoting linear hair growthcomprising administering to a patient not less than 100 mg/kg, or 8-16grams daily, of gelatin for at least three months. That patent disclosesthat lower dosages of gelatin are not sufficient to produce an effect onhair growth. Furthermore, the gelatin, when administered in capsularform, was found to be irritating to the subjects, and was thereforeprovided in yogurt.

US Patent Application No. 20010870424 discloses a method of stimulatinghair growth comprising administering intradermally or subdermally, ahydrogel matrix comprising gelatin and a long chain carbohydrate.

U.S. Pat. No. 4,863,950 is directed to a composition for stimulatingkeratinogenesis and reducing facial and scalp seborrhea formulated assolid spherules comprising about 2 grams “soft” gelatin and about 800 mgL-cysteine. According to the disclosure of this patent, the effect ofstimulation of keratinogenesis and reduction of seborrhea is due to theassociation of “soft” gelatin with cysteine, thereby offering resultswhich are superior to those yielded by presently available formulationswhich contain only gelatin or only cysteine, or which contain both indifferent proportions. In fact, the data presented in the '950 patentindicate that animals fed a normal diet with a gelatin supplement for 20weeks show adverse results, i.e. a slight reduction in the sulphur andcysteine content of the hair keratin.

Different formulations comprising gelatin are taught in the art. Forexample, U.S. Pat. No. 5,928,664 teaches a consumable elastic gummyglycerylated gelatin matrix admixed with an active ingredient. Gelatin,per se, is neither taught nor suggested as an active ingredient.

U.S. Pat. No. 5,760,094 teaches the incorporation of a small amount ofhydrolyzed gelatin into chewable tablets to improve the palatability ofmedicinals.

U.S. Pat. No. 4,495,206 teaches a solid, high protein dietary foodproduct consisting essentially of a gelatin hydrolysate present inquantities equal to or greater than 50% by weight of the product, andone or more members selected from essential amino acids, preservatives,flavoring agents, coloring agents, texturizers and sweeteners.

U.S. Pat. No. 4,997,671 discloses a chewy, semi-plastic,microbiologically stable dog food, which is a dog snack or biscuit. Thatdog snack includes 12 to about 30 weight percent, based upon the totalweight of the dog food, of gelatin; at least one edible acidulant; atleast one edible cereal starch-containing textural agent; at least oneedible release agent; at least one edible taste agent; at least oneedible sugar; salt; and added water.

That patent teaches gelatin as a textural agent and does not teachgelatin as a nutritive supplement having the effect of preventing orcontrolling hair loss and excess shedding.

In their Letter to the Editor, Marganti et al J Soc. Cosmet Chem 1982(33) 95-96, report the use of a combination that comprises 2 grams ofgelatin and 0.8 grams of 1-cystine, promoted more intense hair growthand led to substantial increase in the diameter of the fibers togetherwith the increase in the sulfur content of the hair, which implies thatthe high sulfur protein fraction of hair was affected the most.

There remains a yet unmet need for an edible product useful forpreventing hair loss in humans and animals, which is both palatable andwell tolerated. The art neither teaches nor suggests such a gelatinbased confectionary that provides a dose of gelatin effective forprevention and treatment of mammalian hair loss.

SUMMARY OF THE INVENTION

The art has provided inconsistent and conflicting reports regarding theusefulness of gelatin in preventing or reducing hair loss and promotinghair and nail growth and health. The inventors of the present inventionnow show, in contradistinction to the hitherto known art, that a dailylow oral dose of gelatin is in the form of hydrolyzed gelatin or amixture comprising hydrolyzed gelatin and gelatin, and in particular, inthe form of a malleable edible composition, is able to reduce or preventhair loss in mammals. The term “gelatin as an active agent” as usedherein throughout the specification and claims is used to denote gelatinthat is either in the form of hydrolyzed gelatin or in the form of amixture comprising hydrolyzed gelatin and gelatin.

The present invention provides a palatable composition comprisinggelatin as an active ingredient in an amount sufficient to prevent hairloss in a mammal and to promote hair and nail growth. The composition istasty and has a surprisingly chewy, soft and non-sticky consistency.Furthermore, the composition which comprises gelatin in its hydrolyzedform is unexpectedly amenable to large-scale formulation and production.

In accordance with a first embodiment of the present invention there isprovided an edible composition for use in preventing hair loss in amammal and comprising gelatin as an active agent, and wherein thegelatin present in the edible composition is in the form of hydrolyzedgelatin or a mixture comprising gelatin and hydrolyzed gelatin.

By yet another embodiment of the invention the edible compositioncomprises from about 5% to about 50% (w/w) of gelatin as the activeagent, out of the overall weight of the composition. In accordance witha preferred embodiment of the present invention, in the case that theactive agent, gelatin, is derived from a composition comprising bothgelatin and hydrolyzed gelatin, the percentage of gelatin in thenon-hydrolyzed form in such a mixture shall preferably not exceed 15%(w/w).

In accordance with the present invention the gelatin may be derived froman animal selected from the group of bovine, porcine, ovine, avian andmarine animals. In certain embodiments the gelatin derives from a cow.In specific embodiments the gelatin derives from a fish, and inparticular a fish selected from a kosher species of fish.

By yet another embodiment of the present invention, the compositionoptionally further comprises nutrients useful in prevention of hair lossor promotion of hair growth including one or more members of the groupconsisting of biotin, iron, copper and zinc ions, para-aminobenzoic acid(PABA), linoleic acid, pantothenic acid, vitamin B6, vitamin B12,vitamin A, vitamin C, vitamin D, folic acid, L-methionine, L-cysteineand selenium. Additional vitamins and minerals, which may aid in theprevention of hair loss or promote hair growth, may be included in thecomposition.

In accordance with other embodiments the composition further comprisesfrom about 5 to about 250 mcg of L-methionine and/or from about 1 toabout 200 mcg of sodium selenide, preferably about 100 mg L-methionineand/or 10 mcg sodium selenide. According to another embodiment, thecomposition further comprises from about 0.5 to about 20 mg of zinc.

In another aspect the present invention provides an edible compositionfor promoting hair and nail growth in a mammal provided as aconfectionery, preferably as a palatable, chewy candy. In otherembodiments the composition is provided as a chewy snack or biscuit oras any other form of animal feed.

In a third aspect the present invention provides a method for reducingor preventing hair loss in a mammal comprising the step of:

administering to the mammal an edible composition comprising gelatin asan active agent, wherein the gelatin is in the form of hydrolyzedgelatin or a mixture comprising gelatin and hydrolyzed gelatin, andwherein the edible composition is administered so that the overall doseof the active agent is in the range of from about 0.5 grams to about 7.0grams gelatin per day, preferably from about 1.0 to about 3.0 gramsgelatin per day. More preferably, the dosing concentration is about 1.5grams of total gelatin per day.

In one embodiment the mammal is a human. In other embodiments the mammalis a domestic animal selected from a dog, a cat, a primate, a guineapig, and a rabbit.

The composition may be consumed in one dose or in multiple doses.Likewise, the composition may be consumed one or more times during theday.

In certain embodiments the composition is administered from about 2 toabout 8 weeks. Preferably the composition is administered for about 4 toabout 6 weeks.

These and other embodiments and objects of the present invention willbecome apparent in conjunction with the description and claims thatfollow.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides an edible composition comprising fromabout 5% to about 50% (w/w) hydrolyzed gelatin with or without fromabout 5% to about 15% (w/w) of gelatin, which is able to reduce orprevent hair loss in humans and shedding in animals. Temporary orchronic non-genetic human hair loss is a common result of certainfactors including:

-   -   a) Physical stress arising from surgery or rapid weight change    -   b) Illness including thyroid disorders and pituitary disease,        autoimmune disease, scarlet fever or syphilis;    -   c) Emotional stress and mental illness including anorexia;    -   d) Medications such as high doses of Vitamin A, certain        anticoagulants, gout medications and antidepressants;    -   e) Hormonal changes including pregnancy, childbirth, birth        control pills and devices, menopause;    -   f) Anti-cancer therapy including chemotherapy and radiation;    -   g) Hair abuse such as bleaching, permanents, tight braids and        pony tails, tight wigs, and tight hats.

The compositions and methods are useful for the prophylaxis andtreatment of hair loss in humans and in animals. The compositions areintended as human and veterinary compositions for administration tohumans or animals, respectively. The compositions are useful in treatingchildren experiencing hair loss, including pediatric oncology patients.

The compositions provided by the present invention are capable ofenhancing the actual density of hair, as can be determined by the actualnumber of hairs per area on the scalp; and may increase thekeratinization of the hair.

The basic edible formulation comprises gelatin. Other ingredients mayinclude additional nutrients, natural and intensified sweeteners,acidulants, colors and flavors. This formulation can be modified byusing alternate sugars, varying gelatin levels and blends, and addinggums and starches to reduce the setting time. One objective is achievingthe proper texture, sweetness, flavor release and storage properties.

DEFINITIONS AND EMBODIMENTS

For convenience and clarity certain terms employed in the specification,examples and claims are described herein.

“Growth of hair” and “hair growth” as used herein refers to the growthof the hair from the hair follicle and does not necessarily refer tolinear hair growth. Hair growth is intended to mean that the number ofhairs per unit area is increased as a result of treatment with thecomposition of the present invention, as shown by actual hair counts.Without wishing to be bound to theory, growth of hair may result inincreased keratinization.

Likewise, “hair loss” refers to a decrease in the number of hairs perunit area as shown by actual hair counts.

Hair follicles grow in repeated cycles. One cycle can be broken downinto three phases. Each hair passes through the phases independent ofthe neighboring hairs.

Anagen is the growth phase. Approximately 85% of all hairs are in thisphase at any one time. The anagen phase can vary from two to six yearsand hair grows approximately 10 cm per year.

Catagen is also known as the transitional phase. At the end of theanagen phase the hairs enters into a catagen phase which lasts about oneor two weeks, during which the hair follicle shrinks to about ⅙ of thenormal length. The lower part is destroyed and the dermal papilla breaksaway.

Telogen, or the resting phase, follows the catagen phase and normallylasts about 5-6 weeks. During this time the hair does not grow but staysattached to the follicle while the dermal papilla stays in a restingphase below. Approximately 10-15 percent of all hairs are in this phaseat any one time. At the end of the telogen phase the hair folliclere-enters the anagen phase. The dermal papilla and the base of thefollicle join together again and a new hair begins to form. If the oldhair has not already been shed the new hair pushes the old one out andthe growth cycle starts all over again.

“Gelatin” as used herein refers to a heterogeneous mixture ofwater-soluble proteins of high average molecular weight derived fromcollagen by hydrolytic action. Gelatin may be extracted from animalproducts by acid or base extraction. The difference between the twoforms of extracted gelatin is in the isoelectric point of the resultant,soluble polymer. The type and degree of extraction leads to variousgrades of gelatin. Acid hydrolysis of the collagen leads to Type Agelatin; similarly base hydrolysis leads to Type B gelatin.

Another form of gelatin is the “hydrolyzed gelatin”, which is derivedfrom the standard gelatin by an additional hydrolysis step. Generallymolecular weights of the hydrolyzed gelatins are in the 100,000 Daltonrange.

Gelatin derives from animal origin, for example from bovine, porcine,ovine, avian or marine sources. In certain embodiments the gelatinderives from fish, preferably a kosher fish including cod, haddock andpollock. The use of gelatin derived from fish obviates the health risksthat may be associated with gelatin derived from bovine or ovinesources, but may cause in rare cases allergy to those sensitive to fishproducts.

Mixtures of different types of gelatin are operable.

The preparation of the composition requires considerable expertise inorder to provide a product that is chewable and pleasing to children andadults without being sticky and difficult to chew. Certain parametersmust be adhered to.

Gel strength of the gelatin is rated by the bloom strength, and measuredon a bloom gelometer, known to those having skill in the art. “Bloomstrength” or “bloom” is defined as the weight (measured in grams)required to produce a depression of 4 mm depth in a surface gel by aplate of defined shape and size. The typical strengths of gelatins usedfor chewy “gummi” candies (such as a “Gummi Bear”) is 175 to 250 grams,or bloom.

Without wishing to be bound to theory, gel strength is important inattaining and retaining the gummi structure, because high temperatureand acidic conditions degrade gelatins. Higher gel strengths are lesssusceptible to this degradation. During processing, the temperature mustbe kept high to prevent gelling in the system and to allow dispensing ofthe material.

Gelatin is strongly hydrophilic, absorbing up to ten times its weight ofwater and forming reversible gels of high strength and viscosity. Athermo reversible gelatin is preferred to allow processing and moldingwithout clogging the production system and dispensing the material inthe production lines.

The gelatin used in the compositions of the present invention may beselected from a wide variety of gelatins having a bloom value of about100-375. A 100-250 Bloom strength of gelatin is preferred, although notcritical to the practice of this invention.

Gelatin or hydrolyzed gelatin is employed in the composition of thepresent invention. Preferably, the composition comprises about 5% toabout 15% (w/w) gelatin or about 5% to about 50% (w/w) hydrolyzedgelatin.

“Confectionery” as used herein refers to a palatable, malleable unitthat is chewed comfortably, without harming the teeth and jaws, whilereleasing the nutrients of the gelatin. In certain embodiments thepalatable unit is a chewy candy or candy bar that can be chewed tocompletion.

A dosing regimen is about 1 palatable unit to about palatable units perday. The composition may be consumed in one dose or in multiple doses.Likewise, the composition may be consumed one or more times throughout a24-hour period.

Increased hair density can be observed within about 2 weeks ofadministering gelatin to a subject, but it is preferable that thetreatment continues about 4 to 6 weeks.

Water comprises a part of the inventive system in an amount from about5% to about 20% by weight, more preferably about 10 to 15%.

The term “additive” refers to an ingredient, which can be selected fromone or more nutrients, flavoring agents, colorants, sweeteners such asisomaltitol and syrup maltitol, stabilizers, humectants, fillers,emulsifiers, thickeners and mixtures thereof. Any one or more of theforegoing additional food grade additives may be admixed with thegelatin matrix so as to comprise from about 5% to about 80% by weight ofthe composition.

The term “nutrient” refers to a vitamin, a mineral, an amino acid andother chemical or biological substances intended for use in thetreatment or prevention of hair loss, or the promotion of hair and nailgrowth and quality. Mixtures of nutrients are operable.

Exemplary nutrients optionally added to the composition of the presentinvention one or a mixture of biotin, iron, copper and zinc ions,para-aminobenzoic acid (PABA), linoleic acid, pantothenic acid, vitaminB6, vitamin B12, vitamin A, vitamin C, vitamin D, folic acid,L-methionine, L-cysteine and selenium. Additional vitamins and minerals,which may aid in the prevention of hair loss or promote hair growth, maybe included in the composition.

Biotin is a water-soluble vitamin, generally classified as a B-complexvitamin. Biotin may be added at a concentration of about 1 mcg to about100 mcg per unit. In specific embodiments biotin is included at about 5to about 20 mcg per unit.

L-Methionine: an essential sulphur containing amino acid and may beincluded at about 5 to about 250 mcg per unit. In specific embodimentsL-methionine is included at about 10 to about 30 mcg per unit.

L-Cysteine is an essential sulphur containing amino acid and may beincluded at about 5 to about 100 mcg per unit. In specific embodimentsL-cysteine is included at about 10 to about 30 mcg per unit.

Para-aminobenzoic acid (PABA) is a component of folic acid. Suitableamounts of PABA range from about 1 mg to about 100 mg per unit.

Zinc is an essential trace element that promotes cell proliferation andtissue growth. Zinc may be added as zinc gluconate, zinc sulfate, zincpicolinate or chelated zinc at a concentration of about 0.5 mg to aboutmg zinc per unit. In certain embodiments zinc is included at about 1 toabout 5 mg per unit.

Copper: a trace element that is essential for the formation ofhemoglobin. Copper may be added at a concentration of about 0.1 to about5 mg per unit.

Selenium is a trace element having antioxidant activity. Selenium may beadded to the composition as sodium selenide at about 1 mcg to about 200mcg per unit.

Because zinc, copper and selenium may be toxic to children at highdoses, care is taken to provide a product that will be effective, yetnon-toxic if consumed in a large quantity.

Flavoring agents may be chosen from natural and/or synthetic flavoringagents. Commonly used flavors include menthol, artificial vanilla,cinnamon derivatives, and various fruit flavors, whether employedindividually or in admixture.

An illustrative list of such agents includes volatile oils, syntheticflavor oils, flavoring aromatics, oils, liquids, oleoresins or extractsderived from plants, leaves, flowers, fruits, stems and combinationsthereof. A non-limiting representative list of examples includes citrusoils such as lemon, orange, lime, mandarin and or grapefruit and fruitessences including apple, pear, peach, grape, strawberry, raspberry,cherry, plum, pineapple, apricot and other fruit flavors. Mixtures andderivatives of these materials are contemplated in the presentinvention.

Flavor oils include spearmint oil, peppermint oil, cinnamon oil, and oilof wintergreen (methylsalicylate). Clove oil, bay oil, anise oil,eucalyptus oil, thyme oil, cedar leaf oil, oil of nutmeg, oil of sage,oil of bitter almonds and cassia oil can also be used.

Flavorings such as aldehydes and esters include cinnamyl acetate,cinnamaldehyde, citral diethylacetal, dihydrocarvyl acetate, eugenylformate and p-methylamisol. Further examples of aldehyde flavoringsinclude, but are not limited to acetaldehyde (apple); benzaldehyde(cherry, almond), anisic aldehyde (licorice, anise); cinnamic aldehyde(cinnamon); citral, i.e., alpha citral (lemon, lime); ethyl vanillin(vanilla, cream); hellotropine, i.e., piperonal (vanilla, cream);vanillin (vanilla, cream); alpha-amyl cinnamaldehyde (spicy fruityflavors); butyraldehyde (butter, cheese); valcraldehyde (butter,cheese); citronellal; decannal (citrus fruits); aldehyde C-8 (citrusfruits); aldehyde C-9 (citrus fruits); aldehyde C-12 (citrus fruits);2-ethylbutyraldehyde (berry fruits); tolyl aldehyde (cherry, almond);veratraldehyde (vanilla); 2,6-dimethyl-5-heptenal, i.e., melonal(melon); 2,6-dimethyloctanal (green fruit); and 2-dodecenal (citrus,mandarin), mixtures thereof and the like.

The amount of flavoring agent employed is normally a matter ofpreference subject to such factors as flavor type, base type andstrength desired. In general, amounts up to about 5% by weight of theflavor agents are usable. In certain embodiments the flavor agent ispresent from about 0.2% to about 0.5% by weight.

The present invention encompasses according to certain embodiments theinclusion of both natural and intensive, also known as artificial,sweeteners. Any sweetener that is generally recognized as safe (GRAS) issuitable in the present invention. The sweeteners may be chosen from thefollowing non-limiting list: saccharide such as sucrose, glucose (cornsyrup), dextrose, invert sugar, fructose, and mixtures thereof;saccharin and its various salts such as the sodium salt; dipeptidesweeteners such as aspartame and neotame; plant derived terpenoids andflavenoids including glycyrrhizin and Stevia Rebaudiana (Stevioside);chloro derivatives of sucrose such as sucralose.

For dietary and health reasons it may be desirable to provide asugarless formulation in which the sweeteners are be replaced withpolyhydric alcohols and mixtures of these alcohols, sugar alcohols suchas sorbitol, mannitol, xylitol, erythritol and maltitol andacesulfame-K, and sodium and calcium salts thereof.

In certain embodiments of the present invention, a combination ofnatural and intensive sweeteners is used.

Natural sweetener, i.e. isomaltitol and syrup maltitol, levels can be ashigh as about 80% weight of total dry solids, but more typically arefrom about 50% to about 70% weight percent. The high-intensitysweeteners i.e. aspartame, acesulfame K, saccharin, and sucralose areused at lower concentrations, depending on their potency and the levelof sweetness desired in the composition.

Other conventional additives which are useful in the gelatin system ofthe present invention include mineral adjuvants such as calciumcarbonate, magnesium carbonate, alumina, aluminum hydroxide, aluminumsilicate, talc, tricalcium phosphate and the like; as well as mixturesthereof. These mineral adjuvants may also serve as fillers andtexturizing agents.

Emulsifiers such as lecithin, glycerol monostearate, fatty acidmonoglycerides, diglycerides and triglycerides, glycerol triacetate,propylene glycol monostearate and mixtures thereof can also be includedin the gelatin composition of the present invention.

For colorants, certified colors are typically used to color thecomposition. Naturally derived colors are also utilized. Blends andcombinations of colorants yield satisfactory shades for manyapplications.

Certain factors are considered in choosing appropriate colorants,including solubility, dietary limitations, stability to pH, light andheat, and cost.

The final form of the composition is not limited to any shape or sizewhich may be chosen. In some embodiments each palatable unit has avolume of about 1 cm³ to about 10 cm³. Preferably the gelatin mixture isshaped by molding, extrusion or similar techniques known in the art.

Molding starches are used to coat candy molds and ensure the release ofthe cooled product from the molds. Molding starches are typicallyunmodified starches that contain added oil at about 0.1% weight to allowthe mold shape to be formed. Mineral oil or vegetable oils may be used,as they stable and FDA-approved. Products containing vegetable oils mustbe treated with antioxidants such as TBHQ, BHA or BHT to deterrancidity.

The product may be coated with a polishing agent to provide theindividual palatable unit with a bright appearance and color and preventof stickiness and moisture loss. These agents may be composed ofcarnauba wax at about 2%, plus mineral oils, vegetable oils withantioxidants, and medium-chain triglycerides.

Consideration is given to the packaging material, as compatibility withthe polish oils of the final product needs to be established.

Veterinary Product

The present invention further provides an edible composition forhair-bearing animals including domestic animals such as a horse and petssuch as dogs, cats and rabbits comprising as an active ingredient about5% to about 15% (w/w) gelatin. When fed to an animal daily in a properdosage, the composition reduces or eliminates non-seasonal shedding andpromotes healthy skin and a glossy coat, without harmful side effects.

Animals, including humans, do not grow hair continuously, but rather incycles. Each cycle has a growing phase, a transitional phase and aresting phase. These hair cycles are controlled by such factors asnutrition, hormones, state of health, but most importantly, the amountof light and changes in the surrounding temperature. Pets that are keptprimarily indoors tend to experience changes in both temperature andlight all year round. As a result, these pets tend to shed their hair,sometimes profusely, throughout the year.

The composition is formulated for each type of animal in order to avoidingredients that are harmful to that particular animal type. Theformulation for an animal is similar to humans and may be provided as abiscuit, snack, dry food, bone shaped, chewy strip etc.

For example, U.S. Pat. No. 4,997,671 discloses a chewy, semi-plastic,microbiologically stable dog food, which is a dog snack or biscuit. Thatdog snack includes 12 to about 30 weight percent, based upon the totalweight of the dog food, of gelatin; at least one edible acidulant; atleast one edible cereal starch-containing textural agent; at least oneedible release agent; at least one edible taste agent; at least oneedible sugar; salt; and added water. The dog food is in a compactedform.

Example

The following example is to be considered merely as illustrative andnon-limiting in nature.

Methods for Testing Hair Growth

The primary method for testing the compositions' effect on hair growthwas to measure total hair counts using fiber-optic microscopy and acomputer-assisted, manual hair count method.

Secondary measures of efficacy included assessments of hair diameter, aswell as patient and investigator global assessments of improvement inhair growth. These were based on photographs of the scalp using bothmidline and vertex views.

Example The Effect of the Composition on Human Hair Density

Seventy women, recently post partum, experiencing hair loss were given1.5 grams gelatin powder daily for one month by oral administration.About 70% of the women reported a significant decrease in hair loss andincrease in hair density.

Gelatin was given also to children experiencing hair loss. The gelatinwas administered orally with or without multi vitamins. Mothers andchildren easily accepted the gelatin composition as a treatment and thechildren experienced a decrease in hair loss and an increase in hairdensity within about one month.

The gelatin may be provided as is or in combination with vitamins andminerals as described hereinabove. The compositions did not cause anydiscomfort or side effects in either the children or mothers.

While the present invention has been particularly described, personsskilled in the art will appreciate that many variations andmodifications can be made. Therefore, the invention is not to beconstrued as restricted to the particularly described embodiments,rather the scope, spirit and concept of the invention will be morereadily understood by reference to the claims which follow.

1. An edible composition for use in preventing hair loss in a mammal andcomprising gelatin as an active agent, and wherein said gelatin is inthe form of hydrolyzed gelatin or of a mixture comprising hydrolyzedgelatin and gelatin.
 2. An edible composition according to claim 1,wherein gelatin as the active agent comprises from about 5% to about 50%(w/w) of said edible composition.
 3. An edible composition according toclaim 1, further comprising at least one nutrient being a memberselected from the group consisting of biotin, iron, copper and zincions, para-aminobenzoic acid (PABA), linoleic acid, pantothenic acid,vitamin B6, vitamin B12, vitamin A, vitamin C, vitamin D, folic acid,L-methionine, L-cysteine, zinc and selenium.
 4. An edible compositionaccording to claim 3, wherein said at least one nutrient is from about 5to about 250 mcg of L-methionine.
 5. An edible composition according toclaim 2, wherein said at least one nutrient is from about 1 to about 200mcg of sodium selenide.
 6. An edible composition according to claim 3,wherein said at least one nutrient is from about 0.5 to about 20 mg ofzinc.
 7. A method for reducing or preventing hair loss in a mammalcomprising the step of administering to said mammal an ediblecomposition comprising gelatin as an active agent, wherein said gelatinis in the form of hydrolyzed gelatin or a mixture comprising gelatin andhydrolyzed gelatin, and wherein the administering of said ediblecomposition is carried out so that the overall dose of said active agentis in the range of from about 0.5 grams to about 7 grams of totalgelatin per day.
 8. A method according to claim 7, wherein said totaldose is in the range of from about 1.0 grams to about 3.0 grams of totalgelatin per day.
 9. A method according to claim 7, wherein the step ofadministering is carried out by consuming multiple doses during the day.10. A method according to claim 7, wherein the step of administering iscarried out for a period of from about 2 to about 8 weeks.